RIO 112227

GUDID 00848486017446

BASE ARRAY

MAKO SURGICAL CORP.

Patient positioning sensor
Primary Device ID00848486017446
NIH Device Record Key3779e6fc-0ec7-4e26-ae08-6a688fe71638
Commercial Distribution StatusIn Commercial Distribution
Brand NameRIO
Version Model Number112227
Catalog Number112227
Company DUNS175239677
Company NameMAKO SURGICAL CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100848486017446 [Primary]

FDA Product Code

OLOOrthopedic stereotaxic instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00848486017446]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-24

On-Brand Devices [RIO]

00848486021702LAPTOP COMPUTER
00848486020385REGISTRATION ARRAY
00848486017446BASE ARRAY
00848486017026System Irrigation Tube
00848486016319System Irrigation Clip
00848486015879RIO¿ Foot Switch
00848486002916SYSTEM QUICK CONNECT BASE ARRAY
00848486002893KNEE APPLICATION DUAL PIN ARRAY CLAMP
00848486002770KNEE APPLICATION DUAL PIN BASE CLAMP

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